- Takeda Pharmaceuticals (Lexington, MA)
- …the biologics portfolio and provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... data, and drive data-based decisions and solutions. + Experience contributing to regulatory filings for biologics (eg, CMC sections, control strategy… more
- Lilly (Indianapolis, IN)
- …enable or advance drug development and manufacturing + Author/review sections of CMC (Chemistry, Manufacturing, and Controls) regulatory submission documents for ... Communicate and collaborate with partners from scientific areas, including Regulatory , Discovery, Development, and Manufacturing, Medical, Global Patient Safety… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …including INDs, NDAs, amendments, supplements, and annual reports. * Guide regulatory decision-making to support clinical trial design, CMC programs, ... **Overview** The Vice President of Regulatory Affairs will serve as the senior-most ...activities. Cross-Functional Collaboration * Collaborate closely with Clinical Development, CMC , Medical Affairs, and Commercial teams to ensure alignment… more
- ThermoFisher Scientific (Wilmington, NC)
- … regulatory guidelines; advanced knowledge of at least one of the regulatory specialty areas: preclinical, clinical, CMC , publishing, etc. * Advanced ... (Mon-Fri) **Environmental Conditions** Office **Job Description** Join Us as a Director Regulatory Affairs - Make an Impact at the Forefront of Innovation The… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director, Global Regulatory Strategy, Neuroscience** + Will be a key member of the GRSP ... Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area. + Acts… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director, Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and ... executing regulatory strategies across the global drug development lifecycle. This...with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC , commercial) across regions to achieve strategic business goals… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director, Global Regulatory Project Management (Director, Global RPM) is a senior strategic leader responsible for supporting, ... influencing, translating, and executing oncology regulatory strategies across the global drug development lifecycle. This role combines deep regulatory expertise… more
- Parexel (Nashville, TN)
- Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional ... to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client...in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation… more
- Chiesi (Cary, NC)
- …feedback. Who we are looking for This is what you will do As a Regulatory Affairs Intern within Chiesi Global Rare Diseases, you will gain hands-on exposure to the ... end-to-end regulatory lifecycle of innovative therapies for rare diseases in... strategy discussions and selected cross-functional meetings (eg, Clinical, CMC , Quality, Commercial). + Supporting internal process improvement initiatives,… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. Regulatory Policy and Intelligence - US Director **Live** **What you will do** Let's do ... this. Let's change the world. Global Regulatory Policy team engages regulators, industry and professional associations, and patient advocates externally and subject… more